HemorrhageNCT03497338
New Anticoagulation Strategies of VV-ECMO
An observational study of Hemorrhage, run by Xiao Tang at 1 site in China.
Trial summary
Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Mar 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients received ECMO support
Who may be able to join
- age more than 18 years old, VV-ECMO is estimated more than 3 days
Who cannot join
- hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days
Trial locations and contacts
1 site in 1 country.
China1 site
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
About this study
Official title: the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO
Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.
- Conditions
- Hemorrhage
- Medical subject headings
- Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with hemorrhage events
- fatal bleeding; 2) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or 3. bleeding causing a drop in hemoglobin level by 20 g/L or more or requiring transfusion of two units of whole blood or red cells.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Apr 2018
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Xiao Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Tang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497338
- Sponsor's protocol ID
- new anticoagulation of ECMO
- Status last verified
- Mar 2021
- First submitted
- 4 Apr 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy and Safety of New Anticoagulation Strategies of Maintain Normal Clot Rate to Prevent Hemorrhage While VV-ECMO
- ClinicalTrials.gov ID
- NCT03497338
- Acronym / sponsor ID
- new anticoagulation of ECMO
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xiao TangUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 13 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients received ECMO support
Key inclusion criteria (1 listed)
- age more than 18 years old, VV-ECMO is estimated more than 3 days
Key exclusion criteria (1 listed)
- hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants with hemorrhage events
Time frame: 4 weeks
1) fatal bleeding; 2) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; and/or 3. bleeding causing a drop in hemoglobin level by 20 g/L or more or requiring transfusion of two units of whole blood or red cells.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by Xiao Tang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with hemorrhage events (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.